Still on paper TMF for some studies, and have historically collected 2 original wet ink Protocol Signature pages from the Principal Investigators, one for the ISF and one for the TMF. Is this still necessary? Can we retain the original wet ink in the Investigator Site File and take a [U]copy[/U] for the TMF (noting in the TMF that the original is at site), would this cause an issue for our TMF inspections? Or should we make that TMF copy a 'Certified copy', or just continue with 2 wet inks?

26th Feb 2018, 12:21 PM

rammellconsult

There is no obligation on you to maintain originals in the sponsor TMF if originals are available at the site. Copies should usually meet the criteria for a certified copy but recent guidance at the MHRA TMF Forum suggested that they do not expect certified copies if the original is available in the investigator site file. If the original is in the ISF, the MHRA indicated that this is considered to be "filed in the TMF" and therefore the filing is already met. That was my understanding anyway..... I'm sure others will correct if this is the wrong interpretation.
From a legal perspective, there are no specific requirements for where the original are held. It is a company decision based on rules of best evidence.

1st Mar 2018, 10:57 AM

Margit Zehrer

ICH E6(R2) in section 8.2.2 does not differentiate wet ink original or copy. It depends on what your company SOPs define. I know the described historically approach as well. It was connected with arguing about the signature page as an agreement having a kind of contractual meaning - and therefore the wet ink original has been collected. If you collect "only" a copy, you may check with your legal department on the company opinion whether a copy is binding. If you leave the original on site you do not need a "certified copy", as the original is not replaced or destroyed. However, in future also investigational sites will more and more use electronic investigator site files and you shift the challenge of filing, certified copy versus keeping a wet ink original simply to another Party.